FAQs for Patients
What is OraVerse™?How safe is OraVerse?
How well does OraVerse work in reversing soft tissue anesthesia?
Is there anyone that should not receive OraVerse?
What are the potential side effects with OraVerse?
Will I experience more pain if the anesthesia wears off faster?
Will a second injection cause me to experience more pain?
What effect does OraVerse have on the cardiovascular system?
Q. What is OraVerse?
A. OraVerse (phentolamine mesylate) Injection is a local anesthesia reversal agent that accelerates the return to normal sensation and function for patients who want to avoid the unwanted and unnecessary lingering numbness in the lips and tongue after routine dental procedures. This loss of sensation can result in difficulty with smiling, drinking and speaking and can cause uncontrolled drooling. These are unpleasant and unnecessary side effects of the local anesthetic. OraVerse can bring patients back to normal in approximately half the time.
Q. How safe is OraVerse?
A. OraVerse is the first product of its kind to rapidly reverse the effects of a local dental anesthetic. OraVerse has been studied extensively in clinical trials that took place all across the U.S. In these studies, the drug was given to dental patients (aged 4 through 92) and compared to a control group that received no drug. OraVerse was found to be safe and effective for patients aged 6 and older and weighing at least 33 lbs.1
There are no known drug interactions with OraVerse and no contraindications. In these studies, patients taking other medications (such as drugs for heart conditions or thyroid conditions among others) were also given OraVerse and there were no apparent reactions from the drugs interacting with each other. In addition, the side effects (such as injection site pain, bradycardia and pain after the procedure) were mild and usually resolved within 48 hours. There was no difference in pain or use of pain-relievers between the control group and those that received OraVerse. There was only a 1% difference in the number of OraVerse patients reporting injection site pain versus those in the control group.
back to topQ. How well does OraVerse work in reversing soft tissue anesthesia?
A. The average duration of soft tissue numbness following the use of a dental anesthetic is 3-5 hours. OraVerse is administered by your doctor immediately following a procedure, allowing for a return to normal sensation and function in about half the time.
Q. Is there anyone that should not receive OraVerse?
A. OraVerse is not recommended for use in children less than 6 years of age or weighing less than 33 lbs. In the nationwide clinical trials OraVerse was tested in patients physically qualified for routine dental restorative and periodontal maintenance procedures involving local anesthetic with a vasoconstrictor. OraVerse has not been studied in pregnant women. For nursing mothers, it is not known if OraVerse is excreted in human milk so caution should be exercised. Please consult with your medical doctor.
Q. What are the potential side effects with OraVerse?
A. In the clinical trials, there were no serious side effects associated with OraVerse. A few mild side effects were reported and those were resolved within 48 hours. The frequency of side effects was nearly identical between OraVerse and the control groups who did not receive the drug. Patients did not report more pain with OraVerse or use more pain medication than they did with the control.
Q. Will I experience more pain if the anesthesia wears off faster?
A. When the dentist gives you a local anesthetic to keep you comfortable during a procedure, it affects both the tooth and the soft tissue (lips and tongue) separately. The numbness in your tooth wears off much faster than the numbness in your lips and tongue. Typically, the numbness in your tooth wears off in 45-60 minutes and may already be gone when your dentist completes your procedure and gives you OraVerse.
In the clinical trials OraVerse had no apparent effect on the amount of pain patients experienced and their use of pain relievers after the procedure. In these trials, patients underwent routine restorative and periodontal maintenance procedures (e.g., crown preparation, cavity preparation, scaling and root planning) which are not typically associated with post procedural pain.
back to topQ. Will a second injection cause me to experience more pain?
A. The injection for OraVerse is typically given while the tissue is still numb from the anesthetic. In clinical trials, there was only a 1% increase in reported injection site pain for those receiving OraVerse compared to those in the control group (5% vs. 4% respectively).
Q. What effect does OraVerse have on the cardiovascular system?
A. There is no evidence of OraVerse having any effects on vital signs (blood pressure, pulse, respiration and temperature) in clinical trials as compared to control.
